Evaluating a Patient Decision Aid for Thyroid Cancer Treatment Choices
The EMIRATES Study - Development and Evaluation of Thyroid Cancer Patient Decision Aid (PDA-TC) - Pilot Study
This study tests whether a helpful guide can improve how patients with low-risk thyroid cancer make treatment choices with their doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 1 site (Wigan) |
| Trial ID | NCT06855680 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the impact of a Patient Decision Aid (PDA) on shared decision-making in patients with low-risk differentiated thyroid cancer (DTC). Participants will first receive standard care and then, in a subsequent arm, will be introduced to the PDA pamphlet that provides information about treatment options and outcomes. The study will involve two outpatient consultations where patients will discuss their treatment choices with clinicians, and their decision-making experience will be evaluated using the Decisional Conflict Scale questionnaire. The goal is to enhance patient involvement in treatment decisions regarding hemithyroidectomy versus total thyroidectomy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with low-risk well-differentiated thyroid carcinoma sized between 1-4 cm.
Not a fit: Patients with aggressive or advanced thyroid cancer features, such as multifocality or metastasis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients with better information, leading to more personalized treatment decisions and improved satisfaction with care.
How similar studies have performed: Other studies have shown that decision aids can improve patient engagement and satisfaction in treatment choices, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged over 18 * Both genders * Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either: 1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade \[see appendix for the Thy classification\] or 2. Confirmed following diagnostic hemithyroidectomy * Able to communicate in spoken and written English Exclusion Criteria: * Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology) * Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion. * Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases * Patients who are diagnosed with thyroid cancer which is of a familial disease * Patient who is either Pregnant or breast-feeding * Patient with hyper- or hypothyroidism who is a candidate for surgery * Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease * Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis. * Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent * Patient who is not able to read write and speak English
Where this trial is running
Wigan
- Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust — Wigan, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Wanding Yang
- Email: Wanding.Yang@rmh.nhs.uk
- Phone: 02073528171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.